Study to Evaluate Safety, Efficacy and Immunogenicity of Acne mRNA Vaccine in Adults With Moderate to Severe Acne
Recruiting · Phase 1, Phase 2 · NCT06316297
Conditions: Acne
At a glance
- Research payments reported, 2025
- $4.4M
- U.S. investigators named
- 56
- Sites paid
- 48
- Planned or actual enrollment
- 800
About the trial
- Sponsor
- Sanofi Pasteur, a Sanofi Company
- Tested
- Acne mRNA vaccine (biological), Placebo (other)
- Dates
- Started 2024-04-05; completion 2028-11-30
- Results posted
- Not yet
The purpose of the trial is to evaluate the safety, efficacy and immunogenicity of up to 3 intramuscular injections of the Acne mRNA vaccine candidate at up to four dose levels in adult participants aged 18 to 45 years with moderate to severe acne. This trial will consist of a Core Study followed by an optional Long-Term Extension (LTE). The Core Study will consist of: * Two cohorts evaluating the 2-administration regimen (Cohorts A): Sentinel Cohort A and Main Cohort A. * Two cohorts evaluating the 3-administration regimen (Cohorts B): Sentinel Cohort B and Main Cohort B. Participants from Sentinel Cohorts A and B and from Main Cohort A will be invited to an additional 30-month follow up…
From ClinicalTrials.gov, last updated 2026-08-21. Full record, eligibility and contacts (opens in a new tab)
Industry funding
Sanofi Pasteur Inc. reported $4.4M in research payments for this study in 2025 (302 payments).
Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.
U.S. investigators named on this study
- Ramana K. Puppala, M.D. OB-GYN (Obstetrics & Gynecology) · Greenville, AL
- Hessam Aazami, M.D. General Practice · Canoga Park, CA
- Francisco L. Badar III, MD Family Medicine · Cerritos, CA
- Alina Beaton, M.D. Internal Medicine · Burbank, CA
- Donald M. Brandon, M.D. Internal Medicine · San Diego, CA
- Christopher V. Crosby, M.D., PH.D. Mohs Surgery · La Mesa, CA
- Navid Ezra, M.D. Dermatology · Thousand Oaks, CA
- Nella Green, M.D. Infectious Disease · Poway, CA
- Tooraj J. Raoof, MD Internal Medicine · Encino, CA
- Sherry L. Rotunda, M.D. Mohs Surgery · Oceanside, CA
- William Towner, MD Internal Medicine · Los Angeles, CA
- Gerard F. Acloque JR., M.D. Internal Medicine · Hollywood, FL
- Michael J. Bernhardt, MD Dermatology · Jacksonville, FL
- Jessica Bernstein, DO Dermatology · Delray Beach, FL
- Anna H. Chacon, M.D. Dermatology · Coral Gables, FL
- Carlos Cohen, MD Dermatology · Aventura, FL
- Lucinda I. Cuervo, MD General Practice · Miami, FL
- Craig T. Curtis, MD Family Medicine · Kissimmee, FL
- Frank A. Don, D.O. Dermatology · Hallandale Beach, FL
- Brian J. Feinstein, D.O. Dermatology · Delray Beach, FL
- Seth B. Forman, MD Dermatology · Tampa, FL
- Denise M. Guevara, D.O. Dermatology · Tamarac, FL
- Elyse Julian, DO Dermatology · Plantation, FL
- Stephen J. Lockwood, MD Dermatology · Brandon, FL
- Adonis Maiquez, MD Family Medicine · Miami, FL
- Jerome R. Obed, DO Dermatology · Fort Lauderdale, FL
- Enrique Pelayo, MD Internal Medicine · Miami, FL
- David A. Rodriguez, M D Specialist · Miami, FL
- Brent M. Schillinger, MD Dermatology · Delray Beach, FL
- Julio Y. Valdes Liste, M.D. Internal Medicine · Coral Gables, FL
- Timothy J. Hansen, M.D. Mohs Surgery · Ames, IA
- Lena K. Rydberg Freese, D.O. Internal Medicine · West Des Moines, IA
- Rania Agha, M.D. Dermatology · Oakbrook Terrace, IL
- Stephanie Mehlis, M.D. Dermatology · Skokie, IL
- David Z. Othman, M.D., M.H.S.A Dermatology · Chicago, IL
- Kenneth W. Dawes, M.D. Dermatology · Indianapolis, IN
- Sarah C. Jackson, M.D. Dermatology · New Orleans, LA
- Ira H. Thorla JR., M.D. Dermatology · Baton Rouge, LA
- Mark S. Amster, MD Dermatology · Brighton, MA
- Devina Mehta, MD Dermatology · Boston, MA
- Solomon Amster, M.D. Family Medicine · White Lake, MI
- Nouh Mazloum, DO Emergency Medicine · Wayne, MI
- Melody Stone, MD Dermatology · Saint Joseph, MO
- Andrew R. Tegeder, MD Dermatology · Missoula, MT
- Vaishali G. Escaravage, MD Dermatology · Wilmington, NC
- Radhika Shah Dermatology · Newark, NJ
- Raymond L. Cornelison, MD Dermatology · Chickasha, OK
- Stephanie E. Smith-phillips, M Dermatology · Mount Pleasant, SC
- Pezhman Shoureshi, D.O. Dermatology · Thompsons Station, TN
- Haider Afzal, MD Family Medicine · Baytown, TX
- Janet C. Dubois, M.D. Dermatology · Austin, TX
- Christie E. Matter, MD Dermatology · Prosper, TX
- Uyen Ngoc Mui, MD Dermatology · Katy, TX
- Stephen K. Tyring, MD PHD Dermatology · Webster, TX
- Carrie Cobb, M.D. Dermatology · Lynchburg, VA
- Sonja M. Krejci, MD Dermatology · Seattle, WA
Clinicians the company named as principal investigators in its Open Payments reports.
Sites paid to run it
- Michigan Institute of Research $1.5M
- Delricht Llc $367,729
- Elias Research Associates Llc $344,115
- Universal Medical and Research Center, Llc $236,972
- Lone Star Clinical Research Katy $231,916
- Clinosis $195,879
- Joseph Raoof MD $190,102
- Wellquest Clinical $151,624
- Palm Harbor Dermatology PA PAlm Harbor Dermatology PA Dba True Clinical Research $114,276
- Encore Medical Research Llc $112,789
- Jacksonville Center for Clinical Research $100,482
- Encore Medical Research of Boynton Beach Llc $80,729
- California Research Foundation $75,190
- Las Vegas Clinical Trials, Llc $52,144
- Sea Mar Seattlehealth Home Crcsg $51,511
- Moore Clinical Research $50,968
- Alliance for Multispecialty Research,llc $47,975
- West Los Angeles Medical Center $45,731
- Trial Management Associates, Llc $35,295
- Northridge Clinical Trials Llc $33,306
- Health and Life Research Institute, Llc $31,741
- Paradigm Clinical Research Centers, Inc $29,207
- Lynn Helath Science Inst $27,272
- Innovo Research Llc $21,000
- Medisearch Llc $20,514
- Francisco Badar MD Inc $20,316
- Forward Clinical Trials Llc Forcare Clinical Research $19,381
- Alliance Clinical Holdings Llc $18,002
- Scla Management, Llc $17,990
- Carbon Health Technolgies Inc $16,581
- Boeson Research $16,466
- Center for Clinical Studies Ltd LLP $16,144
- Northshore University Healthsystem - Evanston Hospital, IL $14,500
- Zenith Clinical Research $14,327
- Physicians Research Group II Llc $14,115
- Kerlo Research $12,500
- K2 Summit Research Llc $11,540
- Sandhill Research, Llc $11,500
- Univarsal Research Group Llc $11,190
- Artemis Headlands Llc $11,075
- Dawes Fretzin Clinical Research Gro LLC $10,133
- Metromed Clinical Trials $10,075
- Pmg Research,inc Dba Pmg Research of Charleston,llc $10,000
- Dermresearch P A $5,946
- Empire Clinical Research $5,558
- Profound Research Llc $3,884
- The Research and Education Institute for Thr $2,948
- Southcoast Research Center, Inc $1,973
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.